MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-09-04 for DIMENSION? CLINICAL CHEMISTRY SYSTEM RD701 manufactured by Siemens Healthcare Diagnostics Inc - Glasgow.
[4811615]
Out of range, falsely depressed free thyroxin (ft4) and out of range, falsely elevated thyroid stimulating hormone (tsh) qc results were obtained on an instrument which had previously had dimension? Chemistry wash lot rd41041 installed on the dimension system. Patient results were not reported to the physician. Patient treatment was not altered or prescribed on the basis of the out of range qc results. There was no report of adverse health consequences as a result of the out of range qc results.
Patient Sequence No: 1, Text Type: D, B5
[11922517]
The cause of the out of range qc results is return of contamination of an instrument which had previously had chemistry wash lot rd41041 on the instrument. A decontamination of the instrument had occurred after removal of lot rd41041 but contamination returned. Siemens has confirmed bacterial contamination in chemistry wash lot rd41041. A positive bias will be observed on ctni, ltni, tsh, pbnp and lpbn and a negative bias will be seen on ft4 when this lot is first placed on the instrument without recalibration of methods. Recalibration of these assays when using this lot will not correct the problem and may cause falsely high or low results. Siemens issued an urgent medical device recall letter dated july 2014, communication # (b)(4), to all accounts who had received the impacted lot. Subsequently, siemens issued an urgent medical device recall update dated august 2014, communication # (b)(4), to all accounts who had received the impacted lot. Customers were advised of the immediate remedial actions to be taken by the customer who had previously had lot rd41041 on their system: if available, move ctni, ltni, pbnp, lpbn, tsh, and ft4 testing to an alternate instrument, either a dimension system which was not exposed to chemistry wash lot rd41041 or an instrument with an alternate methodology or platform. If the above action is not possible, patient samples must be bracketed with low level qc for all affected assays. Before reporting patient results, qc values processed before and after the patient sample(s) must be within acceptable qc limits. If any qc values are not acceptable, do not report the patient result(s) and contact siemens for direction on further actions. The update stated that siemens would contact customers with details to schedule remedial actions to prevent further contamination of their dimension system.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2517506-2014-00174 |
| MDR Report Key | 4059822 |
| Report Source | 05,06 |
| Date Received | 2014-09-04 |
| Date of Report | 2014-08-13 |
| Date of Event | 2014-08-12 |
| Date Mfgr Received | 2014-08-13 |
| Device Manufacturer Date | 2014-04-13 |
| Date Added to Maude | 2014-09-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JAMES MORGERA |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY PO BOX 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026318356 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE |
| Manufacturer City | NEWARK DE 19714 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19714 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 2517506-07/15/2014-003-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION? CLINICAL CHEMISTRY SYSTEM |
| Generic Name | CHEMISTRY WASH |
| Product Code | KLI |
| Date Received | 2014-09-04 |
| Catalog Number | RD701 |
| Lot Number | RD41041 |
| Device Expiration Date | 2014-10-13 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW |
| Manufacturer Address | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE NEWARK DE 19714 US 19714 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-04 |